Simparica Trio
Opinion
On 8 December 2022, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a group of variations to the terms of the marketing authorisation for the veterinary medicinal product Simparica Trio. The marketing authorisation holder for this veterinary medicinal product is Zoetis Belgium SA.
Simparica Trio is currently authorised as chewable tablets for use in dogs. The group of variations concerns the addition of three new therapeutic indications: for the treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis), for the treatment of demodicosis (caused by Demodex canis), and for the prevention of establishment of thelaziosis (adult Thelazia callipaeda eyeworm infection).
Detailed conditions for the use of this product are described in the summary of product characteristics (SPC), for which an updated version reflecting the changes will be published in the revised European public assessment report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.
1 Applicants may appeal any CVMP opinion, provided they notify the European Medicines Agency in writing of their intention to appeal within 15 days of receipt of the opinion.
Key facts
| Name |
Simparica Trio |
| Agency product number |
EMEA/V/C/004846 |
| International non-proprietary name (INN) or common name |
|
| Species |
Dogs
|
| Active substance |
|
| Date opinion adopted |
08/12/2022 |
| Company name | |
| Status |
Positive |
| Application type |
Post-authorisation |